FDA Medical devices recall ·
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1798-2026
- Date
- (initiated March 19, 2026)
- Company / brand
- B Braun Medical Inc
824 12th Ave, Bethlehem, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 3,158,104 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
Why was it recalled?
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1798-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.